Siemens Atellica Sample Handler Prime Recalled for Software Issues
Siemens Healthcare Diagnostics is recalling 474 Atellica Sample Handler Prime units due to multiple issues identified in the system software that required an update.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The source text describes a software issue requiring an update but does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 474 units of the Atellica Sample Handler Prime, Material Number 11069001. The recall was initiated because multiple issues were identified in the system software which required an update.
The affected products were distributed to numerous US states, including Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Mississippi, North Carolina, Nebraska, New Hampshire, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Washington, West Virginia, Wyoming, and Puerto Rico. The products were also distributed to many foreign countries, including Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Columbia, Croatia, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Latvia, Malaysia, Mexico, Netherlands, Nigeria, Norway, P.R. China, Pakistan, Poland, Portugal, Republic of Korea, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkey, UAE, UK, and Vietnam.
The UDI for the recalled product is 00630414002026. Users should contact Siemens Healthcare Diagnostics for instructions on how to update the system software.
The recalled product
- Product
- Atellica Sample Handler Prime, Material Number 11069001
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- Affected units
- 474
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: 00630414002026
Distribution
Part of a larger recall action
This product is one of 3 recalled by Siemens Healthcare Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Siemens Healthcare Diagnostics, Inc.
See all →- HighSiemens Atellica CH C-Reactive Protein Reagent Recalled for Falsely Elevated Results
FDA (Devices) · 2026-10-07
- SevereSiemens Recalls Emit 2000 Quinidine Assay Due to Precision Issues
FDA (Devices) · 2026-08-26
- SevereSiemens Quinidine Assay Recalled for Precision Errors
FDA (Devices) · 2026-08-26
- HighSiemens Atellica CH Urine Albumin In Vitro Diagnostic Recall
FDA (Devices) · 2026-08-12
- LowSyva Emit Disopyramide Enzyme Immunoassay Calibrator Recalled for Sodium Azide Concentration
FDA (Devices) · 2026-08-12
Same hazard · software defect
See all →- HighPhilips Spectral CT Systems Recalled for Software Issues Affecting Safety
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- ModerateUnited Imaging uCT 550 CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
- ModerateUnited Imaging uMI Panvivo S PET/CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
Similar recalls
- ModerateSiemens Recalls Atellica Sample Handler Prime Due to Software Issues
FDA (Devices) · 2019-02-06
- ModerateSiemens Recalls Atellica Sample Handler Prime Software Due to Behavioral Issues
FDA (Devices) · 2018-10-24
- HighSiemens Atellica Solution and Sample Handler Prime Recalled for Reporting Errors
FDA (Devices) · 2018-05-09
- ModerateSiemens Atellica Sample Handler Software Recall for Diagnostic Errors
FDA (Devices) · 2018-10-24
- HighSiemens Recalls Atellica IM 1300 Analyzer Software Due to Multiple Issues
FDA (Devices) · 2019-02-06
- HighSiemens Atellica Analyzer Software Recall for Multiple System Issues
FDA (Devices) · 2019-02-06